Janssen's Topamax Users Blame Drug for Birth Defects

By Sophia Pearson -
Oct 15, 2013

Johnson & Johnson’s (JNJ) Janssen
Pharmaceuticals failed to inform expectant mothers of risks that
its epilepsy drug Topamax could cause birth defects, a lawyer
for the mother of a Virginia 6-year-old told a jury.

April Czimmer wouldn’t have taken Topamax for more than six
months had she known the risks associated with the drug, her
attorney Tommy Fibich said in opening statements today in state
court in Philadelphia.

Czimmer blames the drug for her son’s cleft palate and lip
and claims Janssen negligently failed to inform patients about
its risks until the U.S. Food and Drug Administration ordered
stronger warnings in 2011.

“It is the pharmaceutical equivalent of a drive-by
shooting,” Fibich said. “The pharmaceutical company, when they
put this drug out into the market knowing it has these causes,
they don’t know who it’s going to hit.”

Janssen said in court papers that it isn’t liable for the
boy’s injuries. Topamax came with FDA-approved prescribing
information that adequately set forth warnings and precautions
associated with its use, the company said.

The company is facing the first two of 63 cases over the
seizure drug this month in Philadelphia. Topamax, approved by
the FDA in 1996, was one of New Brunswick, New Jersey-based
J&J’s top sellers before it lost patent protection in 2009 and
sales plummeted 58 percent to $1.15 billion, according to the
company’s annual report.

Migraine Treatment

Czimmer said she was prescribed Topamax from August 2006
through February 2007 to treat migraines. Her son Blake was born
in September 2007 with defects requiring four surgeries since
birth, Fibich said.

The FDA on March 4, 2011, said preliminary studies
suggested Topamax might contribute to cleft lips and cleft
palates in infants born to women who used the medication during
pregnancy. The government asked the company to update the label
enclosed with the medicine to reflect a stronger classification
and warning for the drug.

The birth defects, known as oral clefts, occur when parts
of the lip or palate do not completely fuse together in the
first trimester of pregnancy, the FDA said. The defects range
from a small notch in the lip to a groove that runs into the
roof of the mouth and nose. The condition, which can lead to ear
infections and problems with eating and talking, often requires
surgery to close the lip and palate.

Raise Risks

Lawyers for mothers who took the drug during pregnancy
claim Janssen knew as early as 2002 that Topamax could raise the
risk of birth defects, according to a master complaint filed in
September 2011.

They claim the company and its predecessor, Ortho-McNeil
Pharmaceutical, promoted Topamax for off-label use since at
least 2001. The off-label uses included weight loss, anxiety
disorders, cluster headaches, sleep apnea, diabetes and
substance abuse, according to court papers.

Janssen aggressively advertised and sold Topamax for these
off-label uses “without any valid scientific evidence” that
supported the use of the drug for the treatment of such
ailments, according to the master complaint.

The company hired outside physicians to promote the drug
for off-label use and implemented programs such as “Doctor-For-a-Day,” in which physicians accompanied sales representatives
on calls to push the drug.

Criminal Case

In April 2010, J&J paid $81 million to resolve criminal and
civil cases over illegal promotion of the drug. A month later,
Ortho-McNeil admitted that it illegally marketed Topamax and
pleaded guilty to a misdemeanor charge of selling a misbranded
drug as part of the settlement.

Judge Arnold New, who is overseeing the lawsuits in
Philadelphia, granted Janssen’s request to bar punitive damages
in the case. He also dismissed an accusation that Janssen failed
to warn patients and claims that the drug was defective in
design, according to a July 16 court order. The trial is going
forward on claims of negligence, fraud and misrepresentation.

The case is Czimmer v. Janssen Pharmaceuticals Inc.,
110503459, Court of Common Pleas, Philadelphia County,
Pennsylvania. The master case is In Re Topamax Litigation,
110602131, Court of Common Pleas, Philadelphia County,
Pennsylvania.